Reglan Failure-To-Warn Claims Are Not Preempted

A decision by the New Jersey Appellate Division has preserved patients’ claims that manufacturers of generic Reglan failed to adequately warn about neurological risks associated with Reglan in use. The court said the companies had dragged their feet in updating the digestion medication’s labeling. The court ruled last month that federal law doesn’t preempt the claims.

The three-judge panel dealt a blow to generics makers including Pliva Inc., Actavis Elizabeth LLC, Teva Pharmaceuticals USA Inc. and Watson Laboratories Inc., which had argued that lower court decisions ran afoul of Hatch-Waxman Act amendments to the Federal Food, Drug and Cosmetic Act (FDCA) and that the responsibility of generic-drug companies to ensure their labeling matches a brand-name product is exclusively federal in nature. In 2012, Judge Carol E. Higbee, then sitting in Atlantic County Superior Court, found that consumers could proceed with claims against generics manufacturers that allegedly failed to timely change their labeling for metoclopramide products to match the brand-name product’s labeling. Judge Higbee, who dismissed other claims against the companies, reached a similar conclusion in 2013 following renewed motions for dismissal or summary judgment. Those decisions are in accord with the U.S. Supreme Court’s 2011 ruling in Pliva Inc. v. Mensing, according to the appellate panel.

As Judge Higbee explained in her 2012 decision, the high court in Mensing effectively held that “generic manufacturers who comply with the U.S. Food & Drug Administration (FDA) requirement that they mimic brand-name manufacturers’ warning labels cannot be held liable under state tort law for failure to warn.” Judge Higbee also said generics manufacturers that failed to update their labels for metoclopramide tablets following the FDA-approved change to the brand-name label were excluded from federal preemption, based on an absence of “sameness.” The court’s opinion stated:

The court found that plaintiffs were precluded from claiming that the generic defendants should have employed “different or stronger” warnings than those approved for Reglan. However, the trial court correctly determined that plaintiffs’ claims based on the generic defendants’ failure to update their warnings to conform to changes made to the brand-name warnings are not preempted by federal law.

The case hinges on a warning that the FDA approved for Reglan’s label in 2004, advising that therapy shouldn’t exceed 12 weeks, as well as a related “black box warning” that the regulator approved in 2009. The Plaintiffs have accused the generics companies of improper delay in updating their labeling and failing to adequately warn about risks from the drug such as tardive dyskinesia, a neurological disorder. The court’s opinion said:

The court correctly found that allowing plaintiffs to assert these claims would not frustrate any of the purposes or objectives that Congress sought to achieve in the Hatch-Waxman amendments to the FDCA. Moreover, plaintiffs are not pursuing state-law claims based on an alleged violation of federal law. They are pursuing state-law products liability claims based on the generic defendants’ alleged failure to provide adequate warnings concerning their products.

The panel relied on the Sixth Circuit’s in Fulgenzi v. Pliva, a decision issued last year. That court found that the FDCA didn’t preempt a Plaintiff’s state-law claim against Pliva for allegedly failing to provide an adequate warning about tardive dyskinesia to the extent that the claim concerned the warning approved for the Reglan label in 2004 and its absence from the generic version, according to Wednesday’s opinion. The claim wasn’t premised on a violation of the FDCA, but instead an independent duty under state law, the opinion said. The panel also rejected the generics manufacturers’ arguments that the claims should be tossed based on the New Jersey Supreme Court’s 2012 decision in Cornett v. Johnson & Johnson.